BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET - ARTHROTEC

    MDR report key: 373946 · Received January 24, 2002

    Report

    Report Number
    MW4003158
    Event Type
    Other
    Date Received
    January 24, 2002
    Date of Event
    December 27, 2001
    Report Date
    January 14, 2002
    Manufacturer
    BIOMET
    Product Code
    MBI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS SURGEON WAS TIGHTENING WASHERLOC CANCELLOUS SCREW (ARTHOTEC 56MM CANCELLOUS SCREW CAT #908856, LOT #486420) THE SCREW BROKE IN HALF LEAVING THE THREADED PORTION IN LEFT TIBIA. THE TOP PORTION WAS RETRIEVED. SURGEON DECIDED TO LEAVE SCREW IN PLACE AND INSERTED FIXATION STAPLE IN ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET - ARTHROTEC CANCELLOUS BONE SCREW MBI BIOMET * 486420

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other